12 HR Oxymorphone Hydrochloride 5 MG Extended Release Oral Tablet

1 INDICATIONS AND USAGE Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Oxymorphone hydrochloride extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 ) Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. ( 1 ) Limitations of Usage Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1) ] , reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.

Amneal Pharmaceuticals LLC

FDA Reported Adverse Reactions
`[1] fatigue` `[2] nausea` `[3] dyspnoea` `[4] diarrhoea` `[5] dizziness` `[6] drug ineffective` `[7] headache` `[8] pain` `[9] asthenia` `[10] fall`

5 years ago

ROUND PURPLE G71

16 HOW SUPPLIED/STORAGE AND HANDLING

OXYMORPHONE HYDROCHLORIDE extended-release tablets, USP are supplied as the following strengths:

OXYMORPHONE HYDROCHLORIDE Extended-Release Tablets USP, 5 mg are purple, round, film-coated extended-release tablets debossed with “G71” on one side and blank on the other side. They are available as follows: Bottles of 30: NDC 64896-695-08 Bottles of 60: NDC 64896-695-13 Bottles of 100: NDC 64896-695-01 Bottles of 1000: NDC 64896-695-03

OXYMORPHONE HYDROCHLORIDE Extended-Release Tablets USP, 7.5 mg are gray, round, film-coated extended-release tablets debossed with “G75” on one side and blank on the other side. They are available as follows: Bottles of 30: NDC 64896-696-08 Bottles of 60: NDC 64896-696-13 Bottles of 100: NDC 64896-696-01 Bottles of 1000: NDC 64896-696-03

OXYMORPHONE HYDROCHLORIDE Extended-Release Tablets USP, 10 mg are orange, round, film-coated extended-release tablets debossed with “G72” on one side and blank on the other side. They are available as follows: Bottles of 30: NDC 64896-697-08 Bottles of 60: NDC 64896-697-13 Bottles of 100: NDC 64896-697-01 Bottles of 1000: NDC 64896-697-03

OXYMORPHONE HYDROCHLORIDE Extended-Release Tablets USP, 15 mg are white, round, film-coated extended-release tablets debossed with “G76” on one side and blank on the other side. They are available as follows: Bottles of 30: NDC 64896-698-08 Bottles of 60: NDC 64896-698-13 Bottles of 100: NDC 64896-698-01 Bottles of 1000: NDC 64896-698-03

OXYMORPHONE HYDROCHLORIDE Extended-Release Tablets USP, 20 mg are green, round, film-coated extended-release tablets debossed with “G73” on one side and blank on the other side. They are available as follows: Bottles of 30: NDC 64896-699-08 Bottles of 60: NDC 64896-699-13 Bottles of 100: NDC 64896-699-01 Bottles of 1000: NDC 64896-699-03

OXYMORPHONE HYDROCHLORIDE Extended-Release Tablets USP, 30 mg are brown, round, film-coated extended-release tablets debossed with “G77” on one side and blank on the other side. They are available as follows: Bottles of 30: NDC 64896-700-08 Bottles of 60: NDC 64896-700-13 Bottles of 100: NDC 64896-700-01 Bottles of 1000: NDC 64896-700-03

OXYMORPHONE HYDROCHLORIDE Extended-Release Tablets USP, 40 mg are orange, round, film-coated extended-release tablets debossed with “G74” on one side and blank on the other side. They are available as follows: Bottles of 30: NDC 64896-701-08 Bottles of 60: NDC 64896-701-13 Bottles of 100: NDC 64896-701-01 Bottles of 1000: NDC 64896-701-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required). Store

OXYMORPHONE HYDROCHLORIDE extended-release tablets securely and dispose of properly [see Patient Counseling Information (17) ] .

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